Vela Diagnostics‘ ViroKey SARS-CoV-2 RT-PCR Test v2.0 has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA), can now be used with the KingFisher FLEX system and Hamilton Microlab STAR platforms.
The same ViroKey SARS-CoV-2 RT-PCR Test v2.0 kit now runs with the KingFisher FLEX, to decrease turnaround time and increase sample throughput. The workflow also maintains VELA’s proprietary SA201 Reporter as part of its workflow, providing pathologists an accurate and clinically relevant report.
Vela Diagnostics is now also offering a Hamilton Microlab STAR option, that has a throughput of 376 samples per run. PCR continues to be performed on the Sentosa SA201, and together with the SA201 Reporter delivers fast and accurate reporting.
“The Hamilton Microlab STAR workflow option comes at a time when many of our customers are still ramping up COVID-19 testing. This high-throughput workflow will allow laboratories to process substantially more samples per day, with less hands-on time and reduced labor cost,” says Steven Wallace, executive vice president.
Workflow test data for both options has been submitted to FDA and acknowledged as a supplement to the ViroKey SARS-CoV-2 RT-PCR Test v2.0 EUA. While the modified test data has not been reviewed by FDA and product changes are in queue for review, commercial availability for the US market is provided through FDA’s EUA distribution policies.
“Our assay workflows have also been tested against, and are able to reliably detect, the Alpha, Beta, Gamma, and Delta variants. This reduces the risk of false negatives that some tests may have,” says Sam Dajani, CEO and executive chairman of the Board.
Vela Diagnostics’ new workflows complement its existing sample-to-result solutions, like the NGS workflow used for Sentosa SQ HIV-1 Genotyping Assay (IVD) on the Sentosa SQ301, and OncoKey SL 60 Plus that is compatible with the MiSeq, NextSeq and NovaSeq. Workflows include automation to replace essential hands-on steps like extraction, PCR setup, library preparation, result analysis and report generation. This reduces technician time, human errors, decreases risk of cross-contamination and improves traceability. Data analysis can be complicated and require skilled bioinformaticians, but VELA’s built-in analysis and interpretation software negates the need for that and produces accurate, clinically relevant reports.